2D Bags
FlowLinX 2D bio bag assemblies are designed for fluid handling in upstream and downstream processing, such as sampling, buffer and media storage, and transportation of drug substance.
Assembly Features
· Multi-layer coextruded film with ULDPE product contact layer
· Available from 50mL to 100L
· Available in 3-port and 4-port configurations
· Superb physical strength and excellent biocompatibility
· Standard bags with needle free sampling port
· Supplied gamma irradiated with sterility assurance
· Aseptically connect using AseptiQuik® or TPE tube welder
· Manufactured in an ISO 7 Cleanroom
· Animal Component Free
Bag Film Overview
· ULDPE Fluid Contact Layer
· USP <85>, Bacterial Endotoxin
· USP <88>, Biological Reactivity Tests, Class VI, In Vivo
· USP <87>, Biological Reactivity Tests, In Vitro
· ISO 10993-4, Hemolysis
· ISO 10993-5, Cytotoxicity
· ISO 10993-6, Implantation
· ISO 10993-10, Irritation and Sensitization
· ISO 10993-11, Systemic Toxicity
· USP <661>, Plastic Packaging Systems
· EP 3.2.2.1, Plastic Containers for Aqueous Solutions for Infusion
· Extractables Testing